Back to resultsHealth Evaluation of Abilify Long-term Therapy (HEALTH)
Primary Purpose
Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Male or female patients between the ages of 18 to 65.
- Having a DSM-IV diagnosis of schizophrenia or schizoaffective disorder.
- Who are currently taking antipsychotic drugs and clinically intolerable or inadequately controlled that is based upon the clinical judgment of the investigator.
Exclusion Criteria:
- Pregnant or breast feeding women or planning a pregnancy.
- Patient received electroconvulsive therapy within 4 weeks before the Screening Visit.
- A known allergy reaction to any antipsychotic medication (including but not limited to haloperidol, chlorpromazine, thioridazine, pimozide, risperidone, quetiapine, ziprasidone).
- Patient has clinically relevant organic, neurological, or cardiovascular diseases.
- Patient has a history of drug or alcohol abuse within the last 12 weeks.
- Acute psychosis, acute suicidal ideation, or any acute psychiatric condition that might require emergent intervention.
- Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
- Having participated other investigational drug study and taken the investigation drug within one month prior to study entry.
- Depot neuroleptics should be discontinued at least 2 months prior to enrollment.
Sites / Locations
- Changhua Christian Hospital
- Cardinal Tien Hospital Hsin Chu Mercy Branch
- Buddhist Tzu Chi General Hospital
- Wei Gong Memorial Hospital
- Chung Shan Medical University Hospital
- National Cheng Kung University Hospital
- Cathay General Hospital
- Tri-Service General Hospital
- National Taiwan University Hospital Yun-Lin Branch
Outcomes
Primary Outcome Measures
Change from baseline in Clinical Global Impression-Severity (CGI-S) scale after 52 weeks treatment.
Secondary Outcome Measures
Change from baseline in CGI-S scale at each visit during the first 39 weeks treatment.
Change from baseline in total score on the Brief Psychiatric Rating Scale (BPRS) at each visit during the treatment period.
Change from baseline in total score on WHOQOL-BREF questionnaire at each visit during the treatment period.
Change from baseline in total score on PANSS (optional) questionnaire at each visit during the treatment period.
Change from baseline in total score on SFS (optional) questionnaire at 12 and 52 weeks treatment.
Change from Visit 2 on POM questionnaire at each visit during the 12-week switching period.
CGI-I scores after 12, 26, 39, and 52 weeks of treatment.
Full Information
NCT ID
NCT00520650
First Posted
August 23, 2007
Last Updated
December 15, 2009
Sponsor
Taiwan Otsuka Pharm. Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT00520650
Brief Title
Health Evaluation of Abilify Long-term Therapy
Acronym
HEALTH
Official Title
Health Evaluation of Abilify Long-term Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Taiwan Otsuka Pharm. Co., Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a post-market surveillance, and the treatment to patients will be depended upon the decision based on physician's clinical judgment. The health profiles during the switching period, after 12 weeks short-term use, and after 52 weeks long-term use of aripiprazole will be recorded and evaluated.
Detailed Description
Further study details as provided by Taiwan Otsuka Pharmaceutical Co., Ltd.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
245 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Primary Outcome Measure Information:
Title
Change from baseline in Clinical Global Impression-Severity (CGI-S) scale after 52 weeks treatment.
Time Frame
Throughout the study
Secondary Outcome Measure Information:
Title
Change from baseline in CGI-S scale at each visit during the first 39 weeks treatment.
Time Frame
Throughout the study
Title
Change from baseline in total score on the Brief Psychiatric Rating Scale (BPRS) at each visit during the treatment period.
Time Frame
Throughout the study.
Title
Change from baseline in total score on WHOQOL-BREF questionnaire at each visit during the treatment period.
Time Frame
Throughout the study.
Title
Change from baseline in total score on PANSS (optional) questionnaire at each visit during the treatment period.
Time Frame
throughout the study
Title
Change from baseline in total score on SFS (optional) questionnaire at 12 and 52 weeks treatment.
Time Frame
Throughout the study.
Title
Change from Visit 2 on POM questionnaire at each visit during the 12-week switching period.
Time Frame
Throughout the study.
Title
CGI-I scores after 12, 26, 39, and 52 weeks of treatment.
Time Frame
Throughout the study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients between the ages of 18 to 65.
Having a DSM-IV diagnosis of schizophrenia or schizoaffective disorder.
Who are currently taking antipsychotic drugs and clinically intolerable or inadequately controlled that is based upon the clinical judgment of the investigator.
Exclusion Criteria:
Pregnant or breast feeding women or planning a pregnancy.
Patient received electroconvulsive therapy within 4 weeks before the Screening Visit.
A known allergy reaction to any antipsychotic medication (including but not limited to haloperidol, chlorpromazine, thioridazine, pimozide, risperidone, quetiapine, ziprasidone).
Patient has clinically relevant organic, neurological, or cardiovascular diseases.
Patient has a history of drug or alcohol abuse within the last 12 weeks.
Acute psychosis, acute suicidal ideation, or any acute psychiatric condition that might require emergent intervention.
Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
Having participated other investigational drug study and taken the investigation drug within one month prior to study entry.
Depot neuroleptics should be discontinued at least 2 months prior to enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Wen Lin, MD
Organizational Affiliation
Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhua Christian Hospital
City
Changhua
Country
Taiwan
Facility Name
Cardinal Tien Hospital Hsin Chu Mercy Branch
City
Hsinchu
Country
Taiwan
Facility Name
Buddhist Tzu Chi General Hospital
City
Hualien
Country
Taiwan
Facility Name
Wei Gong Memorial Hospital
City
Miaoli
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
Cathay General Hospital
City
Taipei
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
Country
Taiwan
Facility Name
National Taiwan University Hospital Yun-Lin Branch
City
Yun-Lin
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Health Evaluation of Abilify Long-term Therapy
We'll reach out to this number within 24 hrs